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Expression of Longevity Genes in Response to Extended Fasting (FEELGOOD)

18. april 2017 oppdatert av: Intermountain Health Care, Inc.
The purpose of this study is to evaluate the effect of fasting on physical changes associated with cardiovascular disease.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

Coronary heart disease (CHD) is the largest contributor to morbidity and mortality in the Western world and is associated with high-calorie diet, high body mass, and a variety of other factors. CHD can lead to myocardial infarction (MI) and other embolic events. A growing body of evidence suggests that relatively low caloric intake in the diets of a variety of animals increases longevity and preliminary evidence among humans indicates that such caloric restriction reduces risk factors for CHD, including cholesterol levels, blood pressure, glucose, and obesity. Caloric restriction has also been shown to alter the expression of certain genes, especially the forkhead box (FOX) O and sirtuin (SIRT) genes whose over-expression has been shown to increase longevity in animal models. Extended avoidance of caloric intake, also called fasting or short-term starvation, has been shown to increase expression of the FOXA genes that have similar sequence and function as the FOXO genes and that have been shown to increase longevity among animals regardless of FOXO function. We recently demonstrated that the risk of CHD was significantly lower among patients who reported a history of routine periodic extended fasting. The two primary hypotheses for this observation are that fasting may improve individual ability to control dietary intake or that fasting may initiate a cascade of protective mechanisms that preserve cellular and metabolic health.

Studietype

Intervensjonell

Registrering (Faktiske)

30

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Forente stater
    • Utah
      • Murray, Utah, Forente stater, 84107-5701
        • Intermountain Medical Center

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 70 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Ja

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  1. The volunteer (male or non-pregnant female, any ethnicity) must be >18 years of age.
  2. The volunteer must either have a body mass index of 25.0-35.0 kg/m2 or the combination of a body mass index of 18.5-24.9 kg/m2 and two or more previously or currently measured symptoms of the metabolic syndrome (fasting glucose≥110 mg/dL, triglycerides≥150 mg/dL, high-density lipoprotein cholesterol<40 mg/dL in males or <50 mg/dL in females, systolic blood pressure≥130 mmHg or diastolic blood pressure≥85 mmHg, or waist circumference≥40 inches in males or ≥36 inches in females [glucose and cholesterol levels may be self-reported]).
  3. The volunteer has not routinely participated in caloric restriction (deliberate limitation of caloric intake of <80% than the FDA-recommended daily caloric intake) within the last 2 years, has not participated in extended fasting (>12 hours at a time) for at least a year, and does not deliberately skip meals as a routine dietary practice.

Exclusion Criteria:

  1. Body mass index <18.5 or >35 kg/m2.
  2. Current active cancer treatment, treatment with immunosuppressive medications, or solid organ transplantation within 1 year.
  3. Presence of immunosuppressive disease, myocardial infarction, peripheral vascular disease, or stroke within the past year.
  4. Use of insulin.
  5. Although it is unlikely fasting will harm the pregnant or lactating woman, the dietary restrictions placed on the participant for the duration of the study may conflict with dietary recommendations for pregnant or lactating women. Women of child bearing potential, therefore, will meet an exclusion if they become pregnant.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Crossover-oppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Annen: Fasting Day First
28±4 hours of water-only fasting followed by 28±4 hours fed
Atferdsmessig: Fasting First
28±4 hours of water-only fasting followed by 28±4 hours fed
Annen: Fed Day First
28± 4 hours fed followed by 28± 4 hours of fasting
Atferdsmessig: Fed First
28± 4 hours fed followed by 28± 4 hours of fasting

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change From Baseline in Participant Glucose When Fasting and Fed
Tidsramme: Baseline and 3 days
Baseline and 3 days
Change From Baseline in Participant Human Growth Hormone (HGH) When Fasting and Fed
Tidsramme: Baseline and 3 days
Baseline and 3 days
Change From Baseline in Participant Insulin When Fasting and Fed
Tidsramme: Baseline and 3 days
Baseline and 3 days
Change From Baseline in Participant Homeostasis Model Assessment-Insulin Resistance (HOMA-IR) When Fasting and Fed
Tidsramme: Baseline and 3 days
HOMA-IR is used to measure the severity of insulin resistance. Healthy Range: 1.0 (0.5-1.4) Less than 1.0 is optimal Above 1.9 indicates early insulin resistance Above 2.9 indicates significant insulin resistance
Baseline and 3 days
Change From Baseline in Participant Glycogen-Like Protein-1 (GLP-1) When Fasting and Fed
Tidsramme: Baseline and 3 days
Baseline and 3 days
Change From Baseline in Participant Adiponectin When Fasting and Fed
Tidsramme: Baseline and 3 days
Baseline and 3 days
Change From Baseline in Participant Fibroblast Growth Factor-21 (FGF-21) When Fasting and Fed
Tidsramme: Baseline and 3 days
Baseline and 3 days
Change From Baseline in Participant White Blood Cell Count (WBC) When Fasting and Fed
Tidsramme: Baseline and 3 days
Baseline and 3 days
Change From Baseline in Participant Hemoglobin When Fasting and Fed
Tidsramme: Baseline and 3 days
Baseline and 3 days
Change From Baseline in Participant Red Blood Cell Count (RBC) When Fasting and Fed
Tidsramme: Baseline and 3 days
Baseline and 3 days
Change From Baseline in Participant Hematocrit When Fasting and Fed
Tidsramme: Baseline and 3 days
Baseline and 3 days
Change From Baseline in Participant Platelet Count When Fasting and Fed
Tidsramme: Baseline and 3 days
Baseline and 3 days
Change From Baseline in Participant Mean Corpuscular Volume (MCV) When Fasting and Fed
Tidsramme: Baseline and 3 days
Baseline and 3 days
Change From Baseline in Participant Mean Corpuscular Hemoglobin (MCH) When Fasting and Fed
Tidsramme: Baseline and 3 days
Baseline and 3 days
Change From Baseline in Participant Mean Corpuscular Hemoglobin Concentration (MCHC) When Fasting and Fed
Tidsramme: Baseline and 3 days
Baseline and 3 days
Change From Baseline in Participant Red Cell Distribution Width (RDW) When Fasting and Fed
Tidsramme: Baseline and 3 days
Baseline and 3 days
Change From Baseline in Participant Mean Platelet Volume (MPV) When Fasting and Fed
Tidsramme: Baseline and 3 days
Baseline and 3 days
Change From Baseline in Participant Bicarbonate When Fasting and Fed
Tidsramme: Baseline and 3 days
Baseline and 3 days
Change From Baseline in Participant Sodium When Fasting and Fed
Tidsramme: Baseline and 3 days
Baseline and 3 days
Change From Baseline in Participant Chloride When Fasting and Fed
Tidsramme: Baseline and 3 days
Baseline and 3 days
Change From Baseline in Participant Blood Urea Nitrogen (BUN) When Fasting and Fed
Tidsramme: Baseline and 3 days
Baseline and 3 days
Change From Baseline in Participant Calcium When Fasting and Fed
Tidsramme: Baseline and 3 days
Baseline and 3 days
Change From Baseline in Participant Potassium When Fasting and Fed
Tidsramme: Baseline and 3 days
Baseline and 3 days
Change From Baseline in Participant Creatinine When Fasting and Fed
Tidsramme: Baseline and 3 days
Baseline and 3 days
Change From Baseline in Participant Total Cholesterol (TC) When Fasting and Fed
Tidsramme: Baseline and 3 days
Baseline and 3 days
Change From Baseline in Participant Low-Density Lipoprotein Cholesterol (LDL-C) When Fasting and Fed
Tidsramme: Baseline and 3 days
Baseline and 3 days
Change From Baseline in Participant High-Density Lipoprotein Cholesterol (HDL-C) When Fasting and Fed
Tidsramme: Baseline and 3 days
Baseline and 3 days
Change From Baseline in Participant Triglycerides When Fasting and Fed
Tidsramme: Baseline and 3 days
Baseline and 3 days
Change From Baseline in Participant TC/HDL Ratio When Fasting and Fed
Tidsramme: Baseline and 3 days
Baseline and 3 days
Change From Baseline in Participant Weight When Fasting and Fed
Tidsramme: Baseline and 3 days
Baseline and 3 days
Change From Baseline in Participant Waist Circumference When Fasting and Fed
Tidsramme: Baseline and 3 days
Baseline and 3 days
Change From Baseline in Participant Systolic Blood Pressure (SBP), Supine When Fasting and Fed
Tidsramme: Baseline and 3 days
Baseline and 3 days
Change From Baseline in Participant Diastolic Blood Pressure (DBP), Supine When Fasting and Fed
Tidsramme: Baseline and 3 days
Baseline and 3 days
Change From Baseline in Participant High Sensitivity C-Reactive Protein (hsCRP) When Fasting and Fed
Tidsramme: Baseline and 3 days
Baseline and 3 days

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Intermountain Health Care, Inc.

Etterforskere

  • Hovedetterforsker: Benjamin D Horne, PhD, Intermountain Medical Center

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. januar 2010

Primær fullføring (Faktiske)

1. august 2010

Studiet fullført (Faktiske)

1. oktober 2010

Datoer for studieregistrering

Først innsendt

28. januar 2010

Først innsendt som oppfylte QC-kriteriene

29. januar 2010

Først lagt ut (Anslag)

1. februar 2010

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

17. juli 2017

Siste oppdatering sendt inn som oppfylte QC-kriteriene

18. april 2017

Sist bekreftet

1. mars 2011

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 154-002

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